Preemptive Analgesia Of Dexmedetomidine Reduces Per-operation Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorChina International Neuroscience Institution
About this trial
Background:Preemptive analgesia is the initiation of analgesic regimen before the onset of nociceptive stimulation, preventing the amplification of pain due to peripheral and central sensitization and thereby reducing subsequent pain. Preemptive analgesia of dexmedetomidine (DEX) in the epidural and subarachnoid space can effectively prevent the central sensitization, and significantly reduce the phantom limb pain, residual pain after one year of lower limb amputation.
Objective: To investigate the per-operative effects of DEX preemptive analgesia.
Method:The patients scheduled noncardiac surgery undergoing general anesthesia were selected and divided into DEX group and Placebo group randmized. The DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and 15min after induction. The Placebo group was infused with equal amounts of normal saline.The Coprimary efficacy outcome was a composite of analgesia effect, one is the Compliance Rate of IOC2 target in intra-operation, another is the the rate of none-to-slight post-operative pain assessed with the p-NRS≦3 at 12 hours after surgery \[Pain numeric rating scale was assessed with the (Numeric Rating Scale, p-NRS)\].
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years to 85 years old,
body mass index (BMI,calculated as weight in kilograms divided by height in meters squared): 18.5~35.
ASA (American Society of Anesthesiologists) Grade I- III;
Scheduled for non-cardiac surgery undergoing general anesthesia
Disqualifiers
disagreed to participate;
body mass index (BMI) of greater 35
American Society of Anesthesiologists (ASA) classification 4 or above;
previous severe central nervous systemheart, liver, kidney or and lung dysfunction ;
Trial design
Design model
Parallel
Treatments tested in this trial
Preemptive Dexmedetomidine injection
DrugThe DEX group was continuously pumped at 1.5 μg /(kg·h) for 15 minutes before induction, and after induction continue infusion 15min.
Sodium Chloride 0.9% Inj
DrugThe Placebo group was infused with equal amounts of isochronous normal saline.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The coprimary efficacy outcome
The rate of intro-operative IOC2 target reachment
Time frame
During the whole operation2
The coprimary efficacy outcome
The rate of none-to-slight post-operative pain, assessed with the (Numeric Rating Scale)p-NRS\< =3 at 24h post-opertively.
Time frame
post-operative 24 hours3
The primary safety outcome
Adverse events and safety outcomes within during 48 h post-operation: hypotension, Hypertension,Bradycardia,Tachycardia,Respiratory depression,Pulse oxygen desaturation and the number of patients which need intervention.
Time frame
During 48 h post-operationSecondary outcomes
1
SBP
systolic blood pressure(intraoperative hemodynamics)
Time frame
During the whole operation2
DBP
dystolic blood pressure(intraoperative hemodynamics)
Time frame
During the whole operation3
MAP
mean arterial pressure(intraoperative hemodynamics)
Time frame
During the whole operation4
HR
Heart rate (intraoperative hemodynamics)
Time frame
During the whole operationSponsors and contacts
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Source ClinicalTrials.gov
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